Assessment of the Glycemic Responses to Nutritional Products (v2.0)

NCT05308147 | Unknown

• 1 other identifier: INQ-2137 v2.0
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or the test product. Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Several nutritional products will be tested over time.

Conditions

Glycemic Response

Keywords

Glycemic response; Glycemic index; Nutritional products; Healthy individuals

Outcome Measures

Primary Outcomes (1)

• The glycemic index of nutritional products

  3 months

Secondary Outcomes (2)

• The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references

  3 months

• The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references

  3 months

Study Arms (6)

Arm 1 (Reference)

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: First Reference product

Arm 2 (Reference)

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: Second Reference product

Arm 3 (Reference)

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: Third Reference product

Arm 4 (Concept)

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: First Concept product

Arm 5 (Concept)

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: Second Concept product

Arm 6 (Concept)

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: Third Concept product

Interventions

First Reference product DIETARY_SUPPLEMENT

Dextrose (containing 25 grams of carbohydrates)

Arm 1 (Reference)

Second Reference product DIETARY_SUPPLEMENT

Dextrose (containing 25 grams of carbohydrates)

Arm 2 (Reference)

Third Reference product DIETARY_SUPPLEMENT

Dextrose (containing 25 grams of carbohydrates)

Arm 3 (Reference)

First Concept product DIETARY_SUPPLEMENT

Infant Formula (containing 25 grams of carbohydrates)

Arm 4 (Concept)

Second Concept product DIETARY_SUPPLEMENT

Infant Formula with new carbohydrate mixture 1 (containing 25 grams of carbohydrates)

Arm 5 (Concept)

Third Concept product DIETARY_SUPPLEMENT

Infant Formula with new carbohydrate mixture 2 (containing 25 grams of carbohydrates)

Arm 6 (Concept)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 65 years
• Body mass index (BMI) between 18.5 and 27 kg/m²

You may not qualify if:

• Known history of gastrointestinal disease, bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2)affect the results.
• Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
• Major trauma or surgical event within 3 months of screening.
• Known intolerance, sensitivity or allergy to test products.
• Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
• History of cancer in the prior two years, except for non-melanoma skin cancer.

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (1)

INQUIS Clinical Research, Ltd

Toronto, Ontario, M5C 2N8, Canada

RECRUITING

Central Study Contacts

Danone Nutricia Research

CONTACT

+31 30 2095 000; register.clinicalresearchnutricia@danone.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 1, 2022
• Study Start: March 17, 2022
• Primary Completion: April 30, 2022
• Study Completion: May 31, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)